check_circleStudy Completed

Hyperphosphatemia

Bayer Identifier:

15074

ClinicalTrials.gov Identifier:

NCT01187628

EudraCT Number:

Not Available

EU CT Number:

Not Available
Long-term study in Chronic Kidney Disease (Extension from Study 14817)

Trial purpose

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).
  • - Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

Trial summary

Enrollment Goal
123
Trial Dates
September 2010 - April 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Wakayama Medical University HospitalWakayama, 641-8510, Japan
Terminated
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Osaka Rosai HospitalSakai, 591-8025, Japan
Completed
Osaka Saiseikai Nakatsu HospitalOsaka, 530-0012, Japan
Completed
Kitano HospitalOsaka, 530-8480, Japan
Completed
Okayama Saiseikai General HospitalOkayama, 700-0013, Japan
Completed
Kurashiki Central HospitalKurashiki, 710-8602, Japan
Terminated
The Jikei University HospitalMinato-ku, 105-8471, Japan
Completed
Chubu Rosai HospitalNagoya, 455-8530, Japan
Completed
Juntendo Tokyo Koto Geriatric Medical CenterKoto, 136-0075, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Narita Memorial HospitalToyohashi, 441-8021, Japan
Completed
Kawashima HospitalTokushima, 770-0011, Japan
Completed
Osaka City General HospitalOsaka, 534-0021, Japan
Terminated
NTT Medical Center TokyoShinagawa, 141-8625, Japan
Completed
Musashino Red Cross HospitalMusashino, 180-8610, Japan
Completed
Shonan Kamakura General HospitalKamakura, 247-8533, Japan
Terminated
Kameda ClinicKamogawa, 296-0041, Japan
Completed
Kainan HospitalYatomi, 498-8502, Japan
Completed
Nagoya Daini Red Cross HospitalNagoya, 466-8650, Japan
Completed
Kyushu Medical CenterFukuoka, 810-8563, Japan
Completed
Kyoto Medical CenterKyoto, 612-8555, Japan
Completed
Beppu Medical CenterBeppu, 874-0011, Japan
Completed
Oita Medical CenterOita, 870-0263, Japan
Completed
Nagoya Medical CenterNagoya, 460-0001, Japan
Completed
Tokyo Medical CenterMeguro-ku, 152-8902, Japan
Completed
Shizuoka Tokushukai HospitalShizuoka, 421-0193, Japan
Terminated
Social Insurance Chukyo HospitalNagoya, 457-8510, Japan
Completed
Tosei General HospitalSeto, 489-8642, Japan
Terminated
Fukuoka University HospitalFukuoka, 814-0180, Japan
Completed
Saga Prefectural Hospital KoseikanSaga, 840-0054, Japan
Completed
Hokkaido Medical CenterSapporo, 063-0005, Japan
Completed
Kimitsu Chuo HospitalKisarazu, 292-8535, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-0001, Japan
Completed
National Fukuoka-Higashi Medical CenterKoga, 811-3195, Japan
Completed
Hyogo Prefectural Amagasaki HospitalAmagasaki, 660-0828, Japan
Completed
Saiseikai Yokohamashi Nanbu HospitalYokohama, 234-8503, Japan
Terminated
Saiseikai Yahata General HospitalKitakyushu, 805-0050, Japan
Completed
Yokohama City Minato Red Cross HospitalYokohama, 231-8682, Japan
Completed
Anjo Kosei HospitalAnjo, 446-8602, Japan

Primary Outcome

  • Incidence of treatment emergent adverse events
    date_rangeTime Frame:
    baseline to Week 60
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

An open-label, long-term extension study of Lanthanum Carbonate 750 to 2,250 mg in hyperphosphatemia in patients with chronic kidney disease not on dialysis (52 weeks extension from Study 14817)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.http://www.bayerpharma.com/en/research-and-development/clinical-trials/trial-finder/index.php